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Capsules with Soluble Estradiol for Intravaginal Administration
专利权人:
ТЕРАПЬЮТИКСМД; ИНК. (US)
发明人:
БЕРНИК Брайан А. (US),АМАДИО Джулия М. (US),ПЕРСИКАНЕР Питер Х.Р. (US),ТОРСТЕЙНССОН Торстейнн (US),КАКЕЙС Дженис Луиза (US)
申请号:
RU2015100531
公开号:
RU2015100531A
申请日:
2013.06.18
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. An encapsulated pharmaceutical composition for intravaginal administration, comprising: a) a therapeutically effective amount of soluble estradiol; and b) a dissolving agent, wherein the dissolving agent is at least one of C6-C12 fatty acids, glycol and their monoglyceride, diglyceride or triglyceride, wherein the pharmaceutical composition does not contain a hydrophilic gel-forming bioadhesive agent. 2. The composition according to claim 1, wherein the composition contains from about 1 microgram to about 25 micrograms of estradiol. 3. The composition according to claim 2, wherein the composition contains from about 1 microgram to about 10 micrograms of estradiol. The composition according to any one of paragraphs. 1-3, in which the composition is encapsulated in a gelatin capsule. 5. The composition of claim 4, wherein the capsule is a soft gelatin capsule. The composition according to paragraphs. 1-3, in which the dissolving agent is at least one of the following: caproic fatty acid ester, caprylic fatty acid ester, capric fatty acid ester, and combinations thereof. The composition according to paragraphs. 1-3 or 5, wherein the dissolving agent is a monoglyceride, diglyceride or triglyceride of at least one C6-C12 fatty acid. The composition according to paragraphs. 1-3 or 5, wherein the dissolving agent is caprylic / capric triglyceride. 9. The composition according to paragraphs. 1-3 or 5, in which the dissolving agent is preferably at least one of C6-C12 fatty acids, glycol and their monoglyceride, diglyceride or triglyceride. 10. The composition of claim 1, wherein the composition further comprises a nonionic surfactant. The composition of claim 10, wherein the nonionic surfactant contains a polyethylene glycol ether and a fatty acid ester. The composition of claim 10, wherein the nonionic surfactant1. Капсулированный фармацевтический состав для интравагинального введения, содержащий:a) терапевтически эффективное количество растворимого эстрадиола; иb) раст
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